Ossicular prosthesis adjusting device

ABSTRACT

An ossicular prosthesis delivery system having an ossicular prosthesis including an enlarged head and a shaft axially, moveably mounted to the head to adjust shaft length. An elongate main body having an operating portion, including a cylindrical through bore, connected to an adjusting portion, including a generally semi-cylindrical upwardly opening channel coaxial with the bore. An end wall at a distal end of the adjusting portion includes a through passage coaxial with the channel and an upwardly opening cavity. An elongate cylindrical plunger has a claw at one end. The plunger is received in the bore with the claw in the channel and an opposite end extending outwardly of the operating portion. The ossicular prosthesis&#39; shaft is positioned in the channel with the head received in the cavity and the plunger is rotatable in the bore to capture the shaft and is reciprocally moveable in the bore to adjust shaft length of the ossicular prosthesis.

FIELD OF THE INVENTION

This invention relates to ossicular prosthesis used for replacement andreconstruction and, more particularly to an adjusting device for anadjustable length ossicular prosthesis.

BACKGROUND OF THE INVENTION

Due to disease, trauma, or congenital malformation, the ossicles of themiddle ear are sometimes damaged. If this damage results in adiscontinuity of bone between the tympanic membrane and the oval window,no sound conducts and hearing loss results. Some or all of theseossicles can be replaced with a small prosthesis.

The use of middle ear prosthesis for reconstructing the ossicular chainhas gone through a myriad of changes over the years. Since each ear hasdifferent anatomical dimensions, the length of middle ear prosthesisvaries, from 2 mm to 8 mm, on average, with each patient. The mostrecent trend in otology is the use of titanium prostheses. These arecommonly offered as a fixed length prosthesis or an adjustable typeprosthesis. The fixed length means that the prosthesis is a one piecedesign and has a determined length at the time of manufacture. Thesetypes of prostheses have to be stocked in the operating room and presenta high volume of inventory available for each given surgery. Adjustabletype prostheses are manufactured in the maximum length dimension and canbe adjusted to proper length by the surgeon at the time of surgery. Theadvantage of the adjustable type prosthesis is that a hospital need onlystock minimum levels of inventory.

The current method of adjusting these types of prosthesis is manual. Thesurgeon uses an instrument or fingers to slide the head of theprosthesis up or down the shaft to a determined length. Once the correctdimension is reached, the surgeon crimps the head to the shaft to createa fixed length prosthesis. This type of procedure creates two problems.The first is the adjustment process itself. It is extremely difficult tomanipulate these micro-sized implants with the hands or specialtyinstruments. Also, during the crimping process, the head may move fromthe exact position the surgeon selected. The second problem is unwantedhandling of a sterile implant. Because the surgeon has to adjust thelength of the implant using his fingers or an instrument, contaminationissues increase. There is also the possibility that the prosthesis couldbe bent or deformed during handling.

The present invention is directed to enhancements in delivery andadjusting for an adjustable type ossicular prosthesis.

SUMMARY OF THE INVENTION

In accordance with the invention, there is provided an ossicularprosthesis adjusting device.

Broadly, there is disclosed in accordance with one aspect of theinvention an ossicular prosthesis adjusting device comprising anelongate main body including an outer wall and a longitudinallyextending through channel. The outer wall is cylindrical at an operatingportion and generally semi-cylindrical at an adjusting portion. Theadjusting portion includes a radially opening cavity at a distal end. Anelongate plunger has a claw at one end. The plunger is received in thechannel with the claw in the adjusting portion and an opposite endextending outwardly of the operating portion so that, in use, anossicular prosthesis can be inserted in the channel adjusting portionwith a head received in the cavity and the plunger is rotatable in thechannel to capture the shaft and is reciprocally moveable in the channelto adjust shaft length of the ossicular prosthesis.

It is a feature of the invention that the main body and the plunger areof plastic construction.

It is another feature of the invention that the main body includes alongitudinally extending slit though the outer wall.

It is still another feature of the invention to provide a cylindricalshield telescopically received on the main body overlying the channel.

It is a further feature of the invention that the main body includes areference marker adjacent the channel.

It is still another feature of the invention that the plunger iscylindrical and includes a notch at one end to provide an end wall, theend wall being bifurcated to define the claw.

It is still a further feature of the invention that the main bodyincludes a semi-circular end wall at the distal end. The end wall has athrough slot smaller in cross section than the channel and the cavity isdisposed in the end wall.

There is disclosed in accordance with another aspect of the invention anossicular prosthesis adjusting device comprising an elongate main bodycomprising an operating portion, including a cylindrical through bore,connected to an adjusting portion, including a generallysemi-cylindrical upwardly opening channel coaxial with the bore. An endwall at a distal end of the adjusting portion includes a through passagecoaxial with the channel and an upwardly opening cavity. An elongatecylindrical plunger has a claw at one end. The plunger is received inthe bore with the claw in the channel and an opposite end extendingoutwardly of the operating portion so that, in use, an ossicularprosthesis shaft can be inserted in the channel with a head received inthe cavity and the plunger is rotatable in the bore to capture the shaftand is reciprocally moveable in the bore to adjust shaft length of theossicular prosthesis.

There is disclosed in accordance with a further aspect of the inventionan ossicular prosthesis adjusting device comprising an elongate mainbody including a generally semi-cylindrical upwardly opening channel. Afirst end wall at an operating end includes a through opening coaxialwith the channel and a second end wall at an adjusting end including athrough passage coaxial with the channel and an upwardly opening cavity.An elongate cylindrical plunger has a claw at one end. The plunger isreceived in the through opening with the claw in the channel and anopposite end extending outwardly of the main body so that, in use, anossicular prosthesis shaft can be inserted in the channel with a headreceived in the cavity and the plunger is rotatable in the channel tocapture the shaft and is reciprocally moveable in the through opening toadjust shaft length of the ossicular prosthesis.

There is disclosed in accordance with yet another aspect of theinvention an ossicular prosthesis delivery system comprising anossicular prosthesis including an enlarged head and a shaft axially,moveably mounted to the head to adjust shaft length. An elongate mainbody comprises an operating portion, including a cylindrical throughbore, connected to an adjusting portion, including a generallysemi-cylindrical upwardly opening channel coaxial with the bore. An endwall at a distal end of the adjusting portion includes a through passagecoaxial with the channel and an upwardly opening cavity. An elongatecylindrical plunger has a claw at one end. The plunger is received inthe bore with the claw in the channel and an opposite end extendingoutwardly of the operating portion. The ossicular prosthesis' shaft ispositioned in the channel with the head received in the cavity and theplunger is rotatable in the bore to capture the shaft and isreciprocally moveable in the bore to adjust shaft length of theossicular prosthesis.

Further features and advantages of the invention will be readilyapparent from the specification and from the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an ossicular prosthesis delivery systemin accordance with the invention including an ossicular prosthesis andan ossicular prosthesis adjusting device in accordance with theinvention;

FIG. 2 is a perspective view similar to FIG. 1 with a protective shieldremoved;

FIG. 3 is a perspective view of a main body of the ossicular prosthesisadjusting device of FIG. 1;

FIG. 3A is a plan view of the main body of FIG. 3;

FIG. 3B is a sectional view taken along the line 3B—3B of FIG. 3A;

FIG. 3C is an end view taken along the line 3C—3C of FIG. 3B;

FIG. 4 is a perspective view of a plunger of the ossicular prosthesisadjusting device of FIG. 1;

FIG. 5 is an elevation view of the ossicular prosthesis of FIG. 1;

FIGS. 6 and 7 comprise partial perspective views, similar to FIG. 2,illustrating rotation of the plunger for selectively capturing theossicular prosthesis in the main body; and

FIGS. 8 and 9 comprise perspective views illustrating reciprocalmovement of the plunger relative to the main body for adjusting shaftlength of the ossicular prosthesis.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1 and 2, an ossicular prosthesis delivery system 10comprises an ossicular prosthesis 12 and an adjusting device 14. Theadjusting device 14 comprises a main body 16, a plunger 18 and aprotective shield 20.

Referring to FIGS. 3, 3A, 3B and 3C, the main body 16 is of elongate onepiece plastic construction including an outer wall 22 between a firstend wall 24 and a second end wall 26. The outer wall 16 is cylindricalat an operating portion 28 adjacent the first end wall 24 andsemi-cylindrical cylindrical at an adjusting portion 30 proximate thesecond end wall 26. The operating portion 28 includes a cylindricalthrough bore 32. The adjusting portion 30 includes a semi-cylindricalupwardly opening channel 34 coaxial with the through bore 32. The secondend wall 26 forms a shoulder 36 at the juncture with the channel 34. Asemi-circular notch 38 in the second end wall 26 is coaxial with thechannel 34. An upwardly opening cavity 40 is provided in the second endwall 26. A plurality of circumferential slots 42 extends around theouter wall 22 at the adjusting portion 30, each a select distance fromthe cavity 40. A pair of longitudinally extending slits 44 extendthrough upper and lower halves of the operating portion of the outerwall 22.

Referring to FIG. 4, the plunger 18 is of elongate one piece plasticconstruction and comprises a cylindrical rod 46 including a notch 48 ata first end 50 to provide an end wall 52. The end wall 52 is frustocircular and is bifurcated by a slot 54 to define a claw 56. An oppositesecond end 58 is used for manipulating the plunger 18, as describedbelow.

An exemplary ossicular prosthesis 12 is illustrated in greater detail inFIG. 5. The ossicular prosthesis 12 includes an enlarged head 60 and ashaft 62. A smaller head 64 is affixed to a distal end 65 of the shaft62. The enlarged head 60 includes a sleeve 66 for receiving the shaft62. Particularly, the shaft 62 extends through the sleeve 66 and thehead 60 to provide simple length adjustment. The ossicular prosthesis 12may otherwise be as generally described in U.S. Pat. No. 6,186,6256,168,625, the specification of which is hereby incorporated byreference herein. As is apparent, other adjustable prostheses could beused with the adjusting device 14 in accordance with the invention.

In an exemplary embodiment of the invention, the ossicular prosthesis 12includes a head 60 which is generally oval shaped viewed at its endhaving dimensions on the order of 0.1 inches wide, 0.14 inches high and0.01 inches thick. The shaft 12 and small head 64 are together about0.25 inches in length. The main body 16 is about ¾ inch long and ¼ inchdiameter. The plunger 18 is about 1 inch long and 0.12 inches indiameter. The through bore 32 is slightly larger than the plunger toreceive the plunger so that the plunger 18 is rotatable and reciprocallymoveable in the through bore 32, as described below.

As generally shown in FIGS. 1 and 2, the plunger 18 is received in thethrough bore 32 with the claw 56 in the channel 34. The opposite end 58extends outwardly of the operating portion 28 beyond the first end wall24. Referring to FIG. 6, the main body adjusting portion 34 accepts theprofile of the ossicular prosthesis 12. Particularly, the enlarged head60 is received in the cavity 40. The shaft 62 is received in theupwardly opening channel 34 with the shaft 62 extending through the clawslot 54 so that the shaft smaller head 64 is captured in the notch 48.The plunger 18 can be rotated as generally illustrated in FIG. 7 so thatthe claw 56 is rotated until the notch 48 opens sidewardly or downwardlyto retain the shaft 62 and thus ossicular prosthesis 12 in the main body16. Thereafter, and with reference to FIGS. 8 and 9, the plunger 18 isreciprocally moveable in the bore 32 to adjust shaft length of theossicular prosthesis. This is illustrated by comparing FIG. 8 in whichthe claw 56 is proximate the middle one of the reference markers 42 andFIG. 9 where the claw 56 is proximate the endmost of the referencemarkers 42 and the shaft 62 extends further outwardly relative to thehead 60.

The slits 44 through the outer wall 22 compensate for variances intolerance of the pusher 18. The slits 44 provide smooth consistentmotion of the reciprocal movement of the pusher 18. The slits 44 alsoact as a lock. When the surgeon grasps the main body operating portion28, the pressure of the fingers lock the plusher 18 in position so thatit will not move.

As described, the plunger 18 uses a catch and release feature describedrelative to FIGS. 6 and 7 so that the shaft 62 of the prosthesis 12 canbe secured to the plunger 18. The catch and release feature is activatedby rotating the plunge 18 approximately 180°, although lesser rotationcan be used. Particularly, the claw 56 provided on the plunger 18 slideswithin the channel 34 of the main body 16 to capture the distal end 65of the prosthesis shaft including the smaller head 64. Because the shaft62 is thus secured to the plunger, when the plunger is depressed orextended, the shaft 62 moves with the plunger 18. This movement isparallel to the main body 18 and perpendicular to the stationery head60. Adjustment in length occurs when the shaft 62 is moved inrelationship to the fixed position of the head 60. The protective shield20, see FIG. 1, is positioned around the outer diameter of the main bodyat the adjusting portion 30. This shield 20 protects the prosthesis head60 from undesired shock movements during transport, as well asstabilizes the prosthesis 12 within the adjusting device 14. Theprosthesis 12 rests in the adjusting device 14 at its longest length.

Thus, in accordance with the invention, the operation of adjustment is asimple mechanical push pull operation in either direction, as shown inFIGS. 8 and 9. The surgeon will grasp the main body 16 at the adjustingportion 30 with a finger grip and use another finger on the plunger 18to slide the plunger 18 to a desired length. The reference markers 42provide a reference point for the surgeon. A separate measuring deviceis used to determine the final measurement of prosthesis adjustment.

The adjusting device 14 is intended to be a single use disposable item.The adjusting device 14 is advantageously supplied as a component withthe prosthesis 12 to form the delivery system 10. The delivery system 10can be provided in sterile packaging ready for adjustment andimplantation.

In the illustrated embodiment of the invention, the main body 16 isillustrated as being generally cylindrical. As is apparent, the outerwall 22 may take various shapes. The plunger 18 and through bore 32 andcavity 34 are advantageously generally cylindrical to provide for bothreciprocal and rotational movement of the plunger 18 relative to themain body 16. As is apparent, if only reciprocal movement is required,then an alternative cross-sectional shape can be used.

Thus, in accordance with the invention, there is provided an ossicularprosthesis delivery system that can be delivered to a surgeon in asterile condition and pre-loaded with a prosthesis.

1. An ossicular prosthesis adjusting device comprising: an elongate mainbody including an outer wall, a semicircular end wall, and alongitudinally extending through channel, the outer wall beingcylindrical at an operating portion and generally semi-cylindrical at anadjusting portion, the adjusting portion including a radially openingcavity at a distal end, and the end wall located at the distal end andhaving a through slot smaller in cross section than the channel, thecavity being disposed in the end wall; and an elongate plunger having alongitudinal axis and a claw at one end, the plunger being received inthe channel with the claw in the adjusting portion and an opposite endextending outwardly of the operating portion so that, in use, anossicular prosthesis shaft can be inserted in the channel at theadjusting portion with a head of the ossicular prosthesis received inthe cavity and the plunger is rotatable about its longitudinal axis inthe channel to capture the shaft and is reciprocally moveable in thechannel to adjust shaft length of the ossicular prosthesis.
 2. Theossicular prosthesis adjusting device of claim 1 wherein the main bodyand the plunger are of plastic construction.
 3. The ossicular prosthesisadjusting device of claim 1 wherein the main body includes alongitudinally extending slit through the outer wall.
 4. The ossicularprosthesis adjusting device of claim 1 further comprising a cylindricalshield telescopically received on the main body overlying the channel.5. The ossicular prosthesis adjusting device of claim 1 wherein the mainbody includes a reference marker adjacent the channel.
 6. The ossicularprosthesis adjusting device of claim 1 wherein the plunger iscylindrical and includes a notch at the one end to provide an end wall,the end wall being bifurcated to define the claw.
 7. The ossicularprosthesis adjusting device of claim 1 wherein the main body includes asemicircular end wall at the distal end, the end wall having a throughslot smaller in cross section than the channel and the cavity isdisposed in the end wall.
 8. An ossicular prosthesis adjusting devicecomprising: an elongate main body comprising an operating portion,including a cylindrical through bore, connected to an adjusting portion,including a generally semi-cylindrical upwardly opening channel coaxialwith the bore, and an end wall at a distal end of the adjusting portionincluding a through passage coaxial with the channel and an upwardlyopening cavity; and an elongate cylindrical plunger having a claw at oneend, the plunger being received in the bore with the claw in the channeland an opposite end extending outwardly of the operating portion sothat, in use, an ossicular prosthesis shaft can be inserted in thechannel with a head of the ossicular prosthesis received in the cavityand the plunger is rotatable in the bore to capture the shaft and isreciprocally moveable in the bore to adjust shaft length of theossicular prosthesis.
 9. The ossicular prosthesis adjusting device ofclaim 8 wherein the main body and the plunger are of plasticconstruction.
 10. The ossicular prosthesis adjusting device of claim 8further comprising a longitudinally extending slit through the mainbody.
 11. The ossicular prosthesis adjusting device of claim 8 furthercomprising a cylindrical shield telescopically received on the main bodyoverlying the channel.
 12. The ossicular prosthesis adjusting device ofclaim 8 wherein the main body includes a reference marker adjacent thechannel.
 13. The ossicular prosthesis adjusting device of claim 8wherein the plunger includes a notch at the one end to provide an endwall, the end wall being bifurcated to define the claw.
 14. An ossicularprosthesis adjusting device comprising: an elongate main body includinga generally semi-cylindrical upwardly opening channel, a first end wallat an operating end including a through opening coaxial with the channeland a second end wall at an adjusting end including a through passagecoaxial with the channel and an upwardly opening cavity; and an elongatecylindrical plunger having a claw at one end, the plunger being receivedin the through opening with the claw in the channel and an opposite endextending outwardly of the main body so that, in use, an ossicularprosthesis shaft can be inserted in the channel with a head of theossicular prosthesis received in the cavity and the plunger is rotatablein the channel to capture the shaft and is reciprocally moveable in thethrough opening to adjust shaft length of the ossicular prosthesis. 15.The ossicular prosthesis adjusting device of claim 14 wherein the mainbody and the plunger are of plastic construction.
 16. The ossicularprosthesis adjusting device of claim 14 further comprising a cylindricalshield telescopically received on the main body overlying the channel.17. The ossicular prosthesis adjusting device of claim 14 wherein themain body includes a reference marker adjacent the channel.
 18. Theossicular prosthesis adjusting device of claim 14 wherein the plungerincludes a notch at the one end to provide an end wall, the end beingbifurcated to define the claw.
 19. An ossicular prosthesis assembly kitcomprising: an ossicular prosthesis including an enlarged head and ashaft axially, moveably mounted to the head to adjust shaft length; anelongate main body comprising an operating portion, including acylindrical through bore and a longitudinally extending slit through theoperating portion, connected to an adjusting portion, including agenerally semi-cylindrical upwardly opening channel coaxial with thebore, and an end wall at a distal end of the adjusting portion includinga through passage coaxial with the channel and an upwardly openingcavity; and an elongate cylindrical plunger having a claw at one end,the plunger being received in the bore with the claw in the channel andan opposite end extending outwardly of the operating portion, theossicular prosthesis shaft being positioned in the channel with the headreceived in the cavity and the plunger is rotatable in the bore tocapture the shaft and is reciprocally moveable in the bore to adjustshaft length of the ossicular prosthesis.
 20. The ossicular prosthesisassembly kit of claim 19 wherein the main body and the plunger are ofplastic construction.
 21. The ossicular prosthesis assembly kit of claim19 further comprising a longitudinally extending slit through the mainbody.
 22. The ossicular prosthesis assembly kit of claim 19 furthercomprising a cylindrical shield telescopically received on the main bodyoverlying the channel.
 23. The ossicular prosthesis assembly kit ofclaim 19 wherein the main body includes a reference marker adjacent thechannel.
 24. The ossicular prosthesis assembly kit of claim 19 whereinthe plunger includes a notch at the one end to provide an end wall, theend wall being bifurcated to define the claw.
 25. A combination of anossicular prosthesis for use in the middle ear and an adjuster therefor,comprising: (a) an ossicular prosthesis including, (i) a first ossicularengaging element including an enlarged flat first head fixed in shapeand sized for placement within the middle ear in contact with anossicular structure, (ii) a flexible sleeve permanently attached to thefirst head, (iii) a shaft that interferes with the sleeve, the shaftmovable through the sleeve upon application of a sufficient push pullforce between the shaft and sleeve and retained by the sleeve uponremoval of the sufficient relative push pull force, and (iv) a secondossicular engaging element fixed to the shaft, and (b) an adjusterincluding, a main body having structure that axially retains the firsthead against axial movement in opposing axial directions, and anelongate plunger having a first end removably longitudinally coupledrelative to the shaft, the plunger movable in a single plane relative tothe structure that axially retains the first head, wherein the shaftlength can be adjusted by moving the plunger relative to the main bodyin the single plane.
 26. A combination according to claim 25, wherein:the structure that axially retains the enlarged head is a cavity definedin the main body.
 27. A combination according to claim 25, wherein: theplunger is movable parallel relative to the structure that axiallyretains the enlarged head.
 28. A combination according to claim 27,wherein: the plunger is non-rotationally reciprocally movable relativeto the structure that axially retains the enlarged head.
 29. Acombination according to claim 27, wherein: the plunger is axiallyrotatable within a bore of the main body.
 30. A combination according toclaim 25, wherein: the plunger radially engages the shaft of theprosthesis.
 31. A combination according to claim 25, wherein: theadjuster and the prosthesis are provided together in sterile packaging.32. A combination of an ossicular prosthesis for use in the middle earand an adjuster therefor, comprising: (a) an ossicular prosthesisincluding, (i) a shaft having first and second ends, (ii) a firstossicular engaging element including an enlarged flat first head fixedin shape and sized for placement within the middle ear in contact withan ossicular structure, the first ossicular engaging elementlongitudinally displaceable on a first end of the shaft, and (iii) asecond ossicular engaging element different in shape and size from thefirst ossicular engaging structure, the second ossicular engagingelement fixed at the second end of the shaft; and (b) an adjusterincluding, a main body having a length, a channel formed in the mainbody parallel with the length, a retaining structure at the end of thechannel, the retaining structure defining a slot oriented transverse tothe length that axially retains the first ossicular engagement structureagainst axial movement in opposing axial directions, and a plurality ofdistance indication markers provided on the main body along at least oneside of the channel, each distance indication marker provided at areferenced distance from the retaining structure, and an elongateplunger closely received within the channel, the plunger movable withinthe channel in a single plane, and having a first end coupled relativeto the shaft, wherein a distance between the first and second ossicularengaging elements can be adjusted by moving the plunger within thechannel relative to the retaining structure.
 33. A combination accordingto claim 32, wherein: the retaining structure includes a bifurcated endwall of the plunger.
 34. A combination according to claim 32, wherein:the shaft is non-threaded.
 35. A combination according to claim 32,wherein: the plunger is provided in a first rotational orientation inwhich to receive the shaft and the second ossicular engagement elementof the otological prosthesis, and a second rotational orientation inwhich to capture the shaft and the second ossicular engagement elementof the otological prosthesis.
 36. A combination according to claim 35,wherein: the first and second rotational orientations are no more than180° apart.
 37. A combination according to claim 32, wherein: theadjuster and the prosthesis are provided together in a sterile package.38. A combination of an ossicular prosthesis and an adjuster therefor,comprising: (a) an ossicular prosthesis including, (i) a first ossicularengagement element including an enlarged flat first head fixed in shape,(ii) a flexible sleeve permanently attached to the first ossicularengagement element, (iii) a shaft provided with longitudinally displacedalternating enlarged and reduced portions with respectively larger andsmaller cross-sectional diameters that are adapted to interlock with thesleeve, the shaft movable through the sleeve upon application of asufficient relative longitudinal force thereto and retained by thesleeve upon removal of the sufficient relative longitudinal force, and(iv) a second ossicular engagement element fixed to the shaft; and (b)an adjuster including, a main body having a length, a channel parallelwith the length, and a retaining structure at the end of the channel,the retaining structure defining a slot oriented transverse to thelength that axially retains the first ossicular engagement structureagainst axial movement in opposing axial directions, and an elongateplunger closely received within the channel, the plunger movable withinthe channel in a single plane, and having a first end coupled relativeto the shaft, wherein a distance between the first and second ossicularengaging elements can be adjusted by moving the plunger within thechannel relative to the retaining structure.